Identity
- Trade Name
- K-FIX® FDA UDI
- Generic Name
- Surgical instrument guard, single-use, sterile FDA UDI
- Device Name
- The pack contains five radel K-FIX® ergonomically profiled pin protectors that has three main functions in foot surgery for protruding wires. It protects patients and/or hospital staff from wire sharp ends. It prevents any inward pin migration as well as reducing bandage size. It allows easy removal of the wire by the surgeon. Its fixation requires no instrument. The protector ball is introduced until firm locking on the wire extremity previously bent. FDA UDI
- Model / Reference
- 119050ND FDA UDI
- Description
- The pack contains five radel K-FIX® ergonomically profiled pin protectors that has three main functions in foot surgery for protruding wires. It protects patients and/or hospital staff from wire sharp ends. It prevents any inward pin migration as well as reducing bandage size. It allows easy removal of the wire by the surgeon. Its fixation requires no instrument. The protector ball is introduced until firm locking on the wire extremity previously bent. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780357490 FDA UDI
- 510(k) Number
- K022597 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Surgical instrument guard, single-use, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical instrument guard, single-use, sterile
K-Fix® by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI a8da6ddf-7fac-486f-b2b6-b6cfe006bc9d 37 fields · synced Jun 8, 2026